39 applicants

Company

KCR · 1 day ago

Principal Biostatistician

United States

Full-time

Remote

Senior Level

5+ years exp

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BiotechnologyClinical Trials

Actively Hiring

No H1B

Hiring Manager

Ariane Moyer

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Responsibilities

Responsible for statistical analysis of all relevant studies;

Develop Statistical Analysis Plan for conducted studies;

Create TLF shells and write specifications for Statistical Programmer;

Provide input for protocol development and develop statistical section of the protocol;

Review eCRF prior to finalization to ensure design criteria are met and all relevant information to support planned analyses is captured;

Works as Statistical Team Lead to monitor and review the progress of the statistical deliverables on the assigned studies;

Responsible for quality assurance of reported results and their statistical interpretation;

Communicate with clients regarding study protocol and/or statistical analysis issues;

Develop Biostatistics knowledge by participating in external trainings and self-training;

Maintain awareness of all statistical guidelines (ICH, EMA, FDA);

Qualification

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Master’s degree in statisticsSASStatistical analysisCDISC data standardsStatistical programmingRPythonClient managementProject management

Required

Master’s degree in statistics or equivalent

At least 5 years of experience in the pharmaceutical, biotechnological industry or CRO

Strong working knowledge of SAS

Excellent written and oral English communication skills, including grammatical/technical writing skills

Ability to establish and maintain effective working relationships with co-workers, managers and clients

Ability to effectively manage multiple tasks and projects

Knowledge of CDISC data standards and models

Preferred

Basics in R and Python

Benefits

A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs